MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-02-21 for SINGLE USE INJECTOR NM-400U-0425 manufactured by Olympus Medical Systems Corp..
[67812375]
The subject device has not been returned to olympus medical systems corp. (omsc) for evaluation. The exact cause could not be conclusively determined. A supplemental report will be submitted, if additional and significant information becomes available at a later time.
Patient Sequence No: 1, Text Type: N, H10
[67812376]
During an unspecified procedure, the needle tube of the subject device could not be retracted into the sheath. Therefore the doctor withdrew the subject device from the scope while the needle tube of the subject device was extended from the sheath. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[73922454]
This is a supplemental report for mfr report # 8010047-2017-00190 to provide additional information. The subject device was returned to olympus medical systems corp. (omsc) for evaluation. The needle tube of the subject device could not be extended from the sheath. Foreign substance adhered between the needle tube and the sheath. The sheath was not kinked. As a result of removing foreign substance, the needle tube could be extended and retracted. As the result of checking the manufacturing record of the same lot, there were nothing abnormal found. Based on the evaluation and the similar cases in the past, the needle tube might not be extended and retracted since frictional resistance between the needle tube and the sheath was increased by foreign substance adhered. Details of foreign substance could not be conclusively determined. The instruction manual of the device has already warned as follows; *should the any irregularity be observed, do not use the instrument; use a spare instead. Damage or irregularity may compromise patient or user safety, for example:posing an infection-control risk, causing tissue irritation, perforation, bleeding or mucous membrane damage, and may result in more severe equipment damage.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2017-00190 |
| MDR Report Key | 6344946 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-21 |
| Date of Event | 2016-12-29 |
| Date Mfgr Received | 2017-03-23 |
| Device Manufacturer Date | 2016-05-25 |
| Date Added to Maude | 2017-02-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR HIROKI MORIYAMA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO |
| Manufacturer Country | US |
| Manufacturer Phone | 8142642517 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SINGLE USE INJECTOR |
| Generic Name | INJECTOR AND SHEATHSET |
| Product Code | FBK |
| Date Received | 2017-02-21 |
| Model Number | NM-400U-0425 |
| Lot Number | K6525 |
| ID Number | 04953170259937 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-21 |